Regeneron seeks FDA emergency authorisation of Covid-19 antibody therapy used by Trump

Although REGN-COV2 is still currently in its trial phases, there have been exceptions allowed by the FDA such as the most recent one with Trump.

By John Diente October 9, 2020 
 
A little over a week ago, Regeneron was in the news when clinical studies of its antibody therapy reported promising results. Although COVID-19 vaccines have been at the centre of attention over the course of the past few months, experts highlighted the fact that a treatment is equally important. Therefore, when United States President Donald Trump was diagnosed positive for the 2019 novel coronavirus, the biotech firm's experimental drug was administered. Now, the company has applied for emergency use authorisation with the Food and Drug Administration (FDA).

According to the statement posted on its website, the group already submitted the documents. "Subsequent to our discussions with regulatory authorities, we have submitted a request to the U.S. Food and Drug Administration for an Emergency Use Authorisation (EUA) for our REGN-COV2 investigational antibody combination for COVID-19," said Regeneron as reported by CNN.

Regeneron continued: "Under our agreement with the U.S. government for the initial doses of REGN-COV2, if an EUA is granted the government has committed to making these doses available to the American people at no cost and would be responsible for their distribution. At this time, there are doses available for approximately 50,000 patients, and we expect to have doses available for 300,000 patients in total within the next few months."

Although REGN-COV2 is still currently in its trial phases, there have been exceptions allowed by the FDA such as the most recent one with Trump. So far, observations made during tests show that it is most effective on people whose immune systems have already begun to fight against the infection. Furthermore, it also apparently reduces the viral load in the nasopharynx, which, in theory, should prevent transmission via respiratory droplets or aerosols.

Trump received a single dose of Regeneron's antibody cocktail, according to a letter issued by White House physician Sean Conley AFP / JIM WATSON

Preliminary data supposedly confirms that there are no alarming side effects, which makes REGN-COV2 fairly safe with proper medical supervision. Meanwhile, others caution against its purported benefits until findings are published on medical journals after being peer-reviewed. With many pharmaceutical companies sharing press releases regarding favourable results from clinical trials, others are suspecting it might be for raising stock prices instead. Majority of healthcare experts agree that the vaccines and treatments might not be publicly available until early in 2021.